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NCT Number: NCT05473507

A Study of Observation and Follow-up in People With Basal Cell Carcinoma

The purpose of this study is to find out more about how Basal Cell Carcimonas/BCCs grow and to learn more effective ways to monitor and treat these common cancers. This study will not provide any type of treatment for the participants' cancer; it is a 3-year observational study to monitor participants' cancer.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Basal Cell Carcinoma Carcinoma Carcinoma, Basal Cell Neoplasms Neoplasms by Histologic Type Neoplasms, Basal Cell Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients 18 years of age or older
  • Diagnosed with at least 1 BCC based on clinical, dermoscopy, RCM and OCT
  • Patients with BCCs that have a diameter smaller or equal to 1.5cm, allowing for 0.5cm growth before reaching the cutoff for stage 2 BCC, which would require removal of the BCC.
  • Patients with BCCs that have a depth smaller or equal to 0.6mm, to allow for tumor growth of 0.2mm before reaching the depth limitation of OCT imaging (0.8mm)
  • Treatment naiive lesions
  • Ability to sign informed consent

Exclusion criteria

  • Immunosuppressed patients, such as those with a primary immunodeficiency caused by a genetic abnormality and a secondary immunodeficiency caused by AIDS, cancer, chemotherapy and other immunomodulating drugs, solid organ transplant recipitents, CLL, aspelenia, and pregnancy).
  • Patients with cancer genetic syndromes that increase risk of BCC (such as basal cell nevus syndrome, xeroderma pigmentosum, epidermolysis bulosa, oculocutaneous albinism, bazex-dupre-christol syndrome, rothmund-thomson syndrome, and epidermodysplasia verruciformis).
  • Patients with BCCs that are clinically suspected as high risk histopathologic subtypes, i.e. indented or sclerotic lesions that are suspected as morpheaform or infiltrative BCCs.
  • Patients with BCCs that have a diameter larger than 1.5cm\\
  • Patients with BCCs that have a depth greater than 0.6mm
  • Patients with BCCs in high risk locations, i.e. "H" area of the face. (is located in the mid-face at the site of the embryologic fusion plates and is generally believed to be associated with more aggressive skin cancers).
  • Patients with BCCs on locations that may compromise an organ function should the tumor enlarge (for example, eyelid).
  • Tumor located on a site that precludes attachment of the RCM device or inability to tolerate imaging procedure (i.e. remain relatively still for multiple short durations of 3- 4 minutes over a total time of 20-30 minutes)
  • Lesions that previously received therapeutic intervention
  • Inability to give informed consent

Treatment and study plan

Digital Dermoscopy

Diagnostic Test

Digital Dermoscopy will be performed every 3 months.

Reflectance confocal microscopy (RCM)

Diagnostic Test

Reflectance confocal microscopy (RCM) will be performed every 3 months.

Optical coherence tomography (OCT)

Diagnostic Test

Optical coherence tomography (OCT) will be performed every 3 months.

Dermtech tape-stripping

Diagnostic Test

Dermtech tape-stripping for genetic analysiswill be performed every 6 months.

Total Skin Examinations

Diagnostic Test

Total Skin Examinations will be performed every 12 months.

Primary outcomes

  1. Change in Basal Cell Carcinoma growth from Baseline

    Time frame: 3 years

    To adequately measure the growth dynamics of tumors, several imaging modalities will be employed. Longest dimension (millimeters) of the lesion from clinical imaging will be the primary measurement of horizontal extent of the lesion. Maximum lesion depth (millimeters) from OCT imaging will be the primary measured of vertical extension.

  2. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: up to 3 years

    To evaluate the feasibility of active follow-up of BCC as a way of managing BCC.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Basal Cell Carcinoma Follow Up Study. A Prospective Study

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jul 26, 2022
Registry last updated
Oct 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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